Device recall
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
- Recall number
- Z-3292-2026
- Event id
- 99759
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- American Contract Systems Inc
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 25, 2026
- Product code
- FDE
- Device type
- Laparoscopy Kit
- Reason
- Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
- Root cause
- Under Investigation by firm
- Quantity
- 1,804 kits total
- Code info
- UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tiffin, OH, United States